Clinical Project Manager in Brea, California at Ormco

Date Posted: 7/29/2019

Job Snapshot

Job Description

Job ID: ORM001677

About Us

For nearly 60 years, Ormco has partnered with the orthodontic community to manufacture innovative products and solutions to enhance the lives of our customers and their patients. Distinguished products range from legacy twin brackets (Inspire ICE™, Titanium Orthos™ and Mini Diamond™) to pioneering the self-ligating appliances with the Damon™ System (including Damon™ Q2 and Damon™ Clear 2). Ormco’s Insignia™ Advanced Smile Design™ provides an all-inclusive customized indirect bonding solution for increased clinical efficiency. From personalized service to professional education programs and marketing support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives. For more information, visit www.ormco.com.



Description

Summary: The Clinical Affairs Project Manager will be responsible for establishing, coordinating, and executing clinical evaluations and related communications in support of Ormco Product Development and Post Market Surveillance activities.  This position manages the design, study preparation, conduct, and close-out of clinical evaluations.  This position establishes and manages internal systems to ensure that clinical evaluations meet all applicable regulations and guidelines.   This position coordinates clinical study activities including IRB initiation, site visits, compliance, data management and analysis, clinical summaries and Clinical Evaluation Reports.

Primary Duties and Responsibilities:
  • Identify and evaluate potential investigators and establish strong relationships with clinical trial sites and staff.
  • Initiates IRB activities to support pre-market studies, as applicable
  • Manage all clinical site interactions (including conduct site monitoring as needed, training, enrolment tracking, clinical trial material and clinical supply requests) and ensure appropriate and timely communications are maintained in order to keep study on-track.
  • Assist with the design and implementation of strategies, plans and practices for clinical trials.
  • Develop and prepare key clinical documents in conjunction with other team members (e.g. protocols, informed consents, amendments, monitoring plans, summary reports).
  • Organize and participate in investigators' meetings.
  • Review, edit and route clinical protocols. 
  • Work with QA/DA and R&D to inure compliance with protocols & evaluations.
  • Assemble clinical packages to be sent to participating clinicians including NDAs, protocols, feedback forms & product.
  • Keep in contact with clinical participants, receive feedback & photos, summarize information received and provide to the PM and/or project team members.
  • Prepare evaluation summary/progress reports necessary for DHF
  • Participate in project team meetings and provide clinical representation.
  • Attend & participate in company sponsored events (Forum, NSM, seminars) and AAO, as required.
  • Lead MDD/MDR Clinical Evaluation Reports (CER) and Post Market Surveillance (PMS)/ Post Market Clinical Follow-up (PMCF) activities in compliance with regulatory requirements/ timeframes.

Additional Duties and Responsibilities:
  • ECR/EO approval for dept in Master Control
  • Deployment & summaries of surveys for post market surveillance compliance.
  • Other duties as assigned.
Critical Success Factors:
  • High intelligence and well-developed analytical skills.
  • Ability to think critically and in tactical and strategic dimensions simultaneously.
  • Unquestionably high ethical standards and attention to reputational and compliance risks.
  • Ability to prioritize tasks in real time and exercise judgment.
  • Clear and organized communications skills (written and verbal)
  • Presence; ability to lead and manage project teams with a range of experience and skills.
  • Analyze complicated issues and boil down to the key points, develop action plans and bring to a successful conclusion. Perseverance and consistency in pursuit of successful outcomes.
  • Must be able to work both independently and as part of a team
  • Proven track record as a leader, willing to be held accountable for deliverables.
  • Must be a hands-on team player, willing to do what it takes to get the job done.

Job Requirements



Qualifications

Education and Experience:                                           
  • Bachelor’s degree in the sciences or life sciences, or a related scientific discipline from an accredited college/university required.
  • Minimum of 5 year’s experience in the dental, healthcare, pharmaceutical or biotech industry in clinical research, publications, and investigator-sponsored trials.
  • Expertise in managing IRB submissions and approval
  • Certified clinical research professional or coordinator (CCRP or CCRC) preferred.
  • Experience managing large complex global clinical trials for medical device products in different phases of the product cycle
  • Strong experience and knowledge of clinical monitoring functions.
  • Strong computer proficiency in MS Word, Excel, MS Project and PowerPoint.

Language Skills:                                                    
  • Ability to read, analyse, interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Must demonstrate ability to effectively present information and respond to questions from groups of managers, clients, customers, and other business entities.
  • Multi-language skills a plus.
  
Physical Demands/Work Environment: 
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf.

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Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.

At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.

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